Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy (DPN) Clinical Trial

Official title:

Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247558
• Other study ID #: M-006
• Status: Completed
• Phase: N/A
• First received: November 17, 2010
• Last updated: July 23, 2012
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2012
• Source: Pamlab, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study will be an observational cohort study utilizing administrative claims data with 100 patients randomly selected taking Metanx® meeting the inclusion and exclusion criteria and 400 propensity score matched patients meeting the same criteria to serve as a control cohort for analyses. This data includes medical, and pharmacy claims from the HealthCore Integrated Research Database for claims submitted during the time period of 01/01/2002 through 06/30/2007.

Description:

The control patients will be matched at a ratio of 4:1 with the Metanx® patients. Covariates used to select the propensity matched patients will include: age; gender; health plan type and region; DCI score; presence/absence of nephropathy; ischemic heart disease; cerebrovascular disease; neoplasm; insulin use; and all-cause health plan costs in the 6-mont pre-index period.

Claims information about patients selected for the study will be followed longitudinally to the end of data availability. This data stream will be used to determine treatment patterns for Metanx®, healthcare resource utilization, and cost.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients must have pharmacy claims for >120 continuous days of Metanx®. This will be defined as at least a 90-day supply dispensed within the first 120 days post-index. The first pharmacy claim for Metanx® will be the index date.

• Patients must have a diagnosis of diabetes prior to or including the index date.

• Patients must have a diagnosis of a peripheral neurological or a peripheral circulation disorder.

• Patients must have a diagnosis of lower limb ulcer.

Exclusion Criteria:

• Patients will be excluded if they have <18 months of eligibility defined as a minimum of 6 months pre and 12 months post-index eligibility.

• Patients will be excluded if they have taken other L-methylfolate containing products (Deplin®, Cerefolin®, Cerefolin NAC®,Neevo®) or other prescription folic acid combination products with >1mg folic acid.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy (DPN)
• Peripheral Nervous System Diseases

Intervention

Other:
• Metanx® (a medical food)
Patient cohort compliant on Metanx® BID therapy for >120 days
• Not treated with Metanx®
Non-treated comparative cohort

Locations

Country	Name	City	State
United States	HealthCore, Inc.	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Pamlab, L.L.C.	HealthCore, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-Cause Health Plan Costs	Total healthcare utilization and costs for patients treated with Metanx® will be compared to total healthcare utilization and costs for control patients who did not receive Metanx®. Cost data will be presented as Mean (SD) and median.	12 months post-index period	No
Secondary	Disease-Attributable Resoure Use and Cost	Disease attributable resource use and costs will be defined as medical claims associated with ICD-9 codes for disease(s) of interest. Total attributable resource use (units) and cost (allowed or paid), if available, will include: pharmacy (medication related to disease of interest); laboratory tests (all claims); office-based encounters and costs; emergency room visits and cost; other outpatient facility (e.g. clinic, home health); in-patient hospitalization; and durable medical equipment.	12 month post-index period	No
Secondary	Demographics of Patients Taking Metanx®	Statistical data including age (at index date); gender; comorbidities; prior and concomitant medications; and Metanx® utilization (e.g. dispensing quantity, number of fills, compliance, and persistency) will be collected to provide a descriptive analysis of the typical Metanx® patient characteristics.	>120 continuous days Metanx® therapy	No